Impact of concomitant bone-targeted therapies (BTT) on outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) without prior chemotherapy (ctx) treated with abiraterone acetate (AA) or prednisone (P).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5037-5037 ◽  
Author(s):  
Fred Saad ◽  
Karim Fizazi ◽  
Matthew R. Smith ◽  
Thomas W. Griffin ◽  
Anil Londhe ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Cox Regression ◽  
Performance Status ◽  
Phase Iii ◽  
End Points ◽  
Opiate Use ◽  
Potential Clinical Benefit ◽  
Ecog Ps ◽  
Post Hoc ◽  
The Impact

5037 Background: BTT can delay symptomatic progression in cancer pts with bone metastases. In a post hoc analysis, we assessed the impact of concomitant BTT on outcomes in a recent large, multinational study in mCRPC pts without prior ctx. Methods: COU-AA-302 was a phase III trial in asymptomatic/mildly symptomatic pts with progressive mCRPC and no prior ctx. 1,088 pts were stratified by ECOG performance status (ECOG-PS, 0 vs 1) and randomized 1:1 to AA 1 g or placebo QD, plus prednisone 5 mg BID. Radiographic progression-free survival (rPFS) and overall survival (OS) were primary end points; secondary end points were times to opiate use, ctx, ECOG-PS deterioration, and PSA progression. The effect of concomitant use of BTT on all end points was assessed retrospectively using a stratified Cox regression model with factors for treatment, concomitant BTT, interaction of treatment and BTT, and baseline covariates. All data were obtained from a prespecified interim analysis at 55% OS events. Results: Median follow-up at the time of analysis was 27.1 mos. Among intent-to-treat (ITT) pts, 184/546 AA and 169/542 P pts received concomitant BTT for treatment of bone metastases, either zoledronic acid (n = 330), other bisphosphonates (n = 16), denosumab (n = 22), and/or other BTT (n = 5). In these pts, concomitant BTT use was associated with improved OS, time to opiate use for cancer pain, and time to ECOG-PS deterioration (Table). Results were similar in a sensitivity analysis including only ITT pts with bone metastases at baseline. Conclusions: In this post hoc, exploratory analysis, concomitant BTT use was associated with delayed symptomatic progression in asymptomatic/mildly symptomatic mCRPC pts. This potential clinical benefit should be investigated in prospective studies. Clinical trial information: NCT00887198. [Table: see text]

Analysis of prognostic factors in patients with advanced relapsed/refractory NSCLC: Cox regression analysis of a randomized phase III trial comparing docetaxel and paclitaxel poliglumex (PPX)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7040-7040 ◽  
Author(s):  
P. Bonomi ◽  
C. Langer ◽  
M. O’Brien ◽  
K. O’Byrne ◽  
B. Bandstra ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cox Regression ◽  
Performance Status ◽  
Stage Iv ◽  
Tumor Stage ◽  
Phase Iii ◽  
Line Treatment ◽  
Phase Iii Trial ◽  
Cox Regression Analysis ◽  
The Impact

7040 Background: A phase III trial compared PPX to docetaxel as 2nd-line treatment in pts with relapsed/refractory advanced NSCLC (STELLAR 2). While overall survival was similar between arms, the need for supportive measures to manage the effects of myelosuppression was significantly reduced in the PPX arm. The current analysis was performed to evaluate determinants of survival in the 2nd-line treatment of NSCLC. Methods: STELLAR 2 enrolled 849 pts, 427 on PPX and 422 on docetaxel; all patients were included in the analysis. Randomization between the study arms was stratified by tumor stage, performance status (PS), start of frontline chemotherapy (< 4 mo vs more than 4 mo), gender, and prior taxane therapy. Univariate and multivariate Cox regression analyses were performed to evaluate the impact of baseline characteristics on overall survival (OS). Results: At randomization, 29% of pts had received prior taxane, 14% were PS2, 80% had stage IV disease, and 31% had started frontline therapy within the prior 4 months. Risk factors significantly affecting survival as determined by multivariate analysis are listed in the table . These factors were consistent when treatment was added to the model. Prior exposure to taxane was not predictive of survival; tumor stage was a significant univariate predictor (p=0.0349), but had relatively less impact in the multivariate model. Conclusion: These analyses identified several factors associated with reduced survival benefit from standard second line therapy. Consequently, alternative treatment strategies may be necessary in patients with poor prognosis. For example, more tolerable agents may enhance the benefit/toxicity ratio in these patients. [Table: see text] [Table: see text]

Pattern of progression in advanced HCC treated with ramucirumab/placebo: Results from two randomized phase III trials (REACH/REACH-2).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 544-544
Author(s):  
Maria Reig ◽  
Peter R. Galle ◽  
Masatoshi Kudo ◽  
Richard S. Finn ◽  
Josep M. Llovet ◽  
...  
Keyword(s):  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Cox Models ◽  
Poor Prognostic Factor ◽  
Advanced Hcc ◽  
Pooled Data ◽  
Phase Iii Trials ◽  
Ecog Ps ◽  
Post Hoc ◽  
The Impact

544 Background: REACH (NCT01140347) and REACH-2 (NCT02435433) studied ramucirumab (RAM) in pts with advanced hepatocellular carcinoma (HCC) following sorafenib; REACH-2 enrolled pts with baseline alpha-fetoprotein (AFP) ≥400 ng/mL, and met its primary endpoint of overall survival (OS) for RAM vs placebo. This post-hoc analysis examined radiological progression patterns (RPP) incidence every 6 weeks per RECIST v1.1, and if RPP were related to OS and post-progression survival (PPS). Methods: Pts with advanced HCC, Child-Pugh A, and ECOG PS 0-1 with prior sorafenib were randomized (REACH 1:1; REACH-2 2:1) to receive RAM 8 mg/kg or placebo Q2W. Among pts with ≥1 RPP (new extrahepatic lesion [NEH], new intrahepatic lesion [NIH], extrahepatic growth [EHG], or intrahepatic growth [IHG]), results were analyzed by trial and for pooled individual patient data of REACH-2 and REACH (AFP ≥400 ng/mL). Cox models evaluated treatment effect of RPP on OS, and prognostic implications of RPP on OS (adjusting baseline ECOG PS, AFP, macrovascular invasion, arm) and on PPS (adjusting ECOG PS, AFP at progression). Results: RPP incidence in the pooled population was: NEH 39%; NIH 24%; EHG 39%; IHG 37%. When examining NEH vs other RPP, PPS was worse among those with NEH in REACH (HR 2.33, 95% CI 1.51, 3.60), REACH-2 (HR 1.49, 95% CI 0.72, 3.08), and the pooled data (HR 1.75, 95% CI 1.12, 2.74). Use of post-discontinuation therapy may have influenced results. OS was also significantly reduced in those with NEH across studies (Table). RAM provided OS benefit in the pooled population, including pts with NEH (HR 0.56, 95% CI 0.39, 0.80). Conclusions: Acknowledging limitations of post-randomization RPP analysis, the emergence of NEH on RAM or placebo may be an independent poor prognostic factor for PPS. The impact of RAM on OS was consistent across all RPP subgroups. Clinical trial information: NCT01140347 and NCT02435433. [Table: see text]

A multicenter, retrospective study on impact of immunotherapy in urothelial carcinoma with bone metastases (Meet-Uro01 Study).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 401-401
Author(s):  
Patrizia Giannatempo ◽  
Laura Marandino ◽  
Daniele Raggi ◽  
Francesco Pierantoni ◽  
Marco Maruzzo ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Urothelial Carcinoma ◽  
Cox Regression ◽  
Advanced Disease ◽  
Performance Status ◽  
Single Agent ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Dismal Prognosis ◽  
Ecog Ps

401 Background: Considerable numbers of patients (pts) with metastatic urothelial carcinoma (mUC) (approximately 25-47%) develop bone metastases (BoM). Their impact on the efficacy of immunotherapy (IO) is not yet sufficiently investigated. We developed a national collaboration on this issue, with the aim to assess the effect of BoM on survival outcomes of immunotherapy-treated pts in a large retrospective cohort. Methods: Data on pts diagnosed with mUC and treated between 07/14 and 08/20 with single-agent immunotherapy (IO) after failure of at least 1 previous line of chemotherapy (CT) for advanced disease, or (neo-)adjuvant CT within 12 months were retrospectively collected across 14 centers. PFS and OS were analyzed using the Kaplan-Meier method. Cox regression analysis was performed evaluating potential prognostic factors for OS and PFS. Each factor was evaluated in univariable (UV) and multivariable (MVA) analysis. Results: A total of 208 evaluable pts treated with single-agent immunotherapy (anti PD-1 n=42; anti PD-L1 n=166) were identified, including 122 without BoM (59% BoM-) and 86 (41%) BoM+. 13% of pts had progressed within 12 months after (neo-)adjuvant CT and 79% after a previous line of platinum-based CT for advanced disease (cisplatin 42.8%; carboplatin 36.5%). The presence of BoM negatively affected performance status (PS) of patients at baseline (ECOG PS 0/1/2 in 58% / 37% / 5% in BoM- vs 38% / 52% / 9% in BoM+; p=0.017). Other baseline characteristics were comparable. BoM+ showed shorter PFS (median 2.0 vs 2.6 months, HR 1.76 [95%CI, 1.31-2.37], p<0.001) and OS (median 3.9 vs 7.8 months, HR 1.59 [95%CI, 1.15-2.20], p=0.005) than BoM-. Probability of being alive was 62% vs 40% after 6 months, 38% vs 23% after 1 year and 24% vs 13% after 2 years, in BoM- and BoM+ respectively. Within each Bellmunt score, PFS and OS of BoM+ pts were shorter compared to BoM-. Both BoM and higher Bellmunt risk score were significantly associated with shorter PFS and OS in UV and MV analyses (Table). Conclusions: Patients with mUC treated with single-agent immunotherapy for BoM+ advanced disease have a dismal prognosis compared with BoM-. Further research is needed to understand the mechanism behind these clinical outcomes. [Table: see text]

Prognostic significance of bone metastases (BM) and bisphosphonate (BIS) therapy in patients with metastatic renal cell carcinoma (mRCC) treated with molecularly targeted agents (MTAs).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4572-4572
Author(s):  
Rana R. McKay ◽  
Xun Lin ◽  
Julia Jane Perkins ◽  
Ronit Simantov ◽  
Toni K. Choueiri
Keyword(s):  
Cox Regression ◽  
Positive Impact ◽  
Prognostic Significance ◽  
Progression Free Survival ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Impact On Survival ◽  
Ecog Ps ◽  
The Impact

4572 Background: BM are frequently present in patients with mRCC. BM cause significant morbidity and are associated with high rates of skeletal related events (SREs). The purpose of this retrospective analysis was to assess the impact of BM and BIS use on outcomes including progression-free survival (PFS) and overall survival (OS) in patients with mRCC. Methods: We conducted a pooled analysis of patients with mRCC treated from 2003-2011 on phase III (NCT00083899, NCT00065468, NCT00678392) and phase II trials (NCT00054886, NCT00077974, NCT00083889, NCT00338884, NCT00137423). Statistical analyses were performed using Cox regression and the Kaplan-Meier method. Results: We identified 2,749 patients treated with sunitinib (n=1,059), sorafenib (n=335), axitinib (n=359), temsirolimus (TEM) (n=208), TEM + interferon-alfa (IFN) (n=208), or IFN (n=560). Most patients were male (71%), had baseline ECOG PS of 0 (47%) or 1 (51%), clear cell histology (91%), and prior nephrectomy (84%). 285 patients (10.4%) received treatment with BIS (zoledronic acid n=233, pamidronate n=57, unspecified n=1). No patients received denosumab. Of the 2,504 patients with data regarding site of metastasis at diagnosis, 31.9% (n=781) had BM. The rate of SREs in patients with BM compared to patients without BM was 6.4% versus 1.4% (p<0.0001). Presence of BM was associated with shorter PFS (5.1 vs. 6.7 months (mo), HR 1.195, 95% CI 1.076-1.328, p<0.0008) and OS (13.2 vs. 20.2 mo, HR 1.292, 95% CI 1.145-1.456, p<0.0001) when compared to those without BM. In patients with BM, the use of BIS was not associated with improved PFS (5.1 vs. 4.9 mo, HR 0.867, 95% CI 0.704-1.067, p=0.1785) or OS (13.3 vs. 13.1 mo, HR 0.904, 95% CI 0.722-1.132, p=0.3801) when compared to patients who did not receive BIS. In patients with BM stratified by type of first-line MTA (TKI, mTOR inhibitor, or IFN-based), use of BIS was not associated with improved PFS or OS. Conclusions: In this analysis, we confirm that the presence of BM is an adverse risk factor for shorter PFS and OS in patients with mRCC treated with MTAs. Treatment with BIS did not have a positive impact on survival in this cohort.

Loco-regional treatment (LRT) for M1 at diagnosis prostate cancer (PCa) patients (pts) and impact on overall survival (OS): A retrospective analysis.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 280-280
Author(s):  
Diletta Bianchini ◽  
David Lorente Estelles ◽  
Pasquale Rescigno ◽  
Hazel 'O Sullivan ◽  
Michael Paul Kolinsky ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Metastatic Disease ◽  
Cox Regression ◽  
De Novo ◽  
Primary Tumour ◽  
Time Interval ◽  
Cox Regression Analysis ◽  
Ecog Ps ◽  
The Impact ◽  
Baseline Psa

280 Background: The optimal management of the primary tumour in pts with M1 at diagnosis PCa is not established. We aimed to evaluate the impact on OS of LRT (surgery or radiotherapy to the primary tumour) in de novo metastatic disease. Methods: PCa pts with M1 disease at diagnosis treated at the Royal Marsden between June 2003 and December 2011 were evaluated. LRT+ patients were defined as those that had received surgery or radiotherapy for the primary. Covariates analysed included age, diagnostic Gleason score, lines of CRPC treatment, PSA, burden of bone metastases ( ≥ 4 vs < 4 bone metastases) and ECOG PS. Kaplan-Meier analyses generated OS data. The association between LRT and OS was evaluated in univariate (UV) and multivariate (MV) Cox regression models. Results: Overall 234 pts with M1 at diagnosis were identified; 27 (11.53%) received LRT (25 XRT; 2 prostatectomy). Median time interval between diagnosis and LRT was 782 days (range 0-4130). Patients receiving LRT were younger (49 vs 61 yrs, p = 0.042), had lower baseline PSA values (68 vs 148; p < 0.001), and were more likely to have lymph node only disease (26% vs 10%; p = 0.029) and a lower burden of bone metastases with < 4 metastases (85% vs 34%;p < 0.001). Patients receiving LRT had a significantly longer survival (74.2 vs 55.1 months; HR 0.39; p < 0.001) in UV and MV cox-regression analysis (table). LRT+ remained highly prognostic, independently of disease volume at diagnosis and baseline PSA. Conclusions: LRT was associated with increased survival in patients with de novo metastatic disease, and in these analyses the prognostic utility of this LRT prognostic biomarker was independent of volume of metastatic disease at baseline and I'd baseline PSA. Other possible confounder factors may need to be taken into account when interpreting these results which require prospective validation from clinical trials such as STAMPEDE . [Table: see text]

Phase III randomized, placebo-controlled trial of L-carnitine supplementation for fatigue in patients with cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20532-e20532 ◽  
Author(s):  
R. A. Cruciani ◽  
J. Zhang ◽  
J. B. Manola ◽  
D. Cella ◽  
B. Ansari ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Performance Status ◽  
Carnitine Deficiency ◽  
Phase Iii ◽  
Carnitine Supplementation ◽  
Open Label ◽  
Severe Fatigue ◽  
Significant Depression ◽  
Ecog Ps ◽  
The Impact

e20532 Background: Carnitine deficiency has been reported in pts with cancer. This study was done to determine the prevalence of carnitine deficiency and the impact of supplementation on fatigue. Methods: Between November 2005 and January 2007, 376 pts with an invasive malignancy and normal hemoglobin levels with fatigue assessed as moderate or severe (score of 2 or higher on “I feel fatigued” question on FACIT-F) within 4 wks were randomized to 4 wks of supplementation with oral carnitine (n=189) or placebo (n=187) 1000 mg twice daily with meals. All pts then received 4 wks of open-label carnitine. Pts were stratified on gender, performance status (PS), and current receipt of chemotherapy. Quality of life was assessed at baseline, wk 4, and wk 8. The study was designed to detect a difference of 0.5 standard deviations in the change of average daily fatigue between the arms at 4 wks using the Brief Fatigue Index (BFI). Results: More than half of pts were male, had metastatic disease and were currently receiving chemotherapy. At study entry, 15% had ECOG PS 2–3, 39% were taking analgesics and 28% were taking antidepressants. There was no difference in the change in scores from baseline to wk 4 on the BFI, FACIT-F, Brief Pain Index (BPI) severity, BPI interference, or CES-D between arms (Wilcoxon p=0.56, 0.62, 0.61, .64, 0.93, respectively). The proportion of pts with severe fatigue or significant depression declined over time on both arms. Carnitine deficiency was defined using the acyl:free carnitine ratio and free carnitine levels. Deficiency levels were 34%, 11%, and 14% among pts randomized to carnitine and 32%, 33%, and 11% among pts randomized to placebo at baseline, wk 4, and wk 8, respectively (p<0.001 at 4 wks). An exploratory analysis suggests an improvement among pts who were carnitine deficient at the beginning of supplementation. Conclusions: Carnitine supplementation reduced deficiency levels but did not have a significant effect on fatigue, pain or depression. Analyses of carnitine metabolites are ongoing. No significant financial relationships to disclose.

Impact of antibiotics (ABX) on overall survival (OS) in patients (pts) with advanced non-small-cell lung cancer (aNSCLC) and melanoma (aMel) treated with first-line immune checkpoint inhibition (ICI).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20643-e20643 ◽  
Author(s):  
Stephen Joseph Bagley ◽  
Neil Dhopeshwarkar ◽  
Vivek Narayan ◽  
Neal J. Meropol ◽  
Ronac Mamtani ◽  
...  
Keyword(s):  
Cox Regression ◽  
Time Window ◽  
Negative Impact ◽  
Performance Status ◽  
Secondary Analysis ◽  
First Line ◽  
Primary Analysis ◽  
Retrospective Cohort Studies ◽  
Ecog Ps ◽  
The Impact

e20643 Background: Recent data suggest that modulating the microbiome may affect response to ICI. Using electronic health record (EHR) data, we examined whether use of ABX influences OS in pts with aNSCLC and aMel treated with ICI. Methods: We performed two retrospective cohort studies (aNSCLC, aMel) of pts who received ICI +/- chemotherapy as first-line treatment in the nationwide Flatiron Health EHR-derived database. The impact of ABX exposure on OS was assessed using Cox regression, adjusting for age, sex, body mass index (BMI), performance status (ECOG PS), Elixhauser Comorbidity Index, glucocorticoid (GC) use, and smoking. In the primary analysis, ABX exposure was defined as use from -6 to +4 weeks around start of ICI. In secondary analyses, we separately evaluated ABX use within 6 weeks pre- and 4 weeks post-initiation of ICI. Results: Baseline characteristics are displayed (Table). In the primary analysis, there was no association between ABX use and OS in aNSCLC (HR 1.16, 95% CI 0.54-2.47, p = 0.7) or in aMel (HR 0.70, 95% CI 0.17-2.81, p = 0.6). The only secondary analysis to reveal a negative impact of ABX on OS was the time window of 0 to +4 weeks after ICI start in aNSCLC (HR 3.41, 95% CI 1.38-8.39, p = 0.008). Conclusions: In this large, real-world dataset, ABX exposure around the start of front-line ICI did not influence OS in pts with aNSCLC or aMel. However, ABX exposure was associated with inferior OS in the subgroup of aNSCLC pts who received ABX within 4 weeks following start of ICI. Further characterization of completeness of ABX exposure data in the oncology EHR will assist with interpretation of these results. [Table: see text]

Radium-223 chloride (Ra-223) impact on skeletal-related events (SREs) and ECOG performance status (PS) in patients with castration-resistant prostate cancer (CRPC) with bone metastases: Interim results of a phase III trial (ALSYMPCA).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4551-4551 ◽  
Author(s):  
A. Oliver Sartor ◽  
Daniel Heinrich ◽  
Joe M. O'Sullivan ◽  
Sophie D. Fossa ◽  
Ales Chodacki ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Performance Status ◽  
Standard Of Care ◽  
High Energy ◽  
Alpha Particles ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Radium 223 ◽  
Ecog Ps

4551 Background: Ra-223, a 1st-in-class alpha-pharmaceutical, targets bone metastases (mets) with high-energy alpha-particles of short range (<100 μm). ALSYMPCA, a phase III, double-blind, randomized, multinational study, compared Ra-223 plus best standard of care (BSC) v placebo (pbo) plus BSC in patients (pts) with bone mets in CRPC. The primary endpoint was OS; secondary endpoints included SREs and ECOG PS. Methods: Eligible pts had progressive, symptomatic CRPC with ≥ 2 bone mets on scintigraphy and no known visceral mets; were receiving BSC; and either previously received docetaxel, were docetaxel ineligible, or refused docetaxel. Pts were randomized 2:1 to 6 injections of Ra‑223 (50 kBq/kg IV) q4 wks or matching pbo and stratified by prior docetaxel use, baseline ALP level, and current bisphosphonate use. Results: 921 pts were randomized from 6/2008-2/2011. In a planned interim analysis (n = 809), Ra-223 significantly improved OS v pbo (median OS 14.0 v 11.2 mo, respectively; two-sided P = .00185; HR = .695; 95% CI, .552-.875).SREs were lower in the Ra-223 v pbo group, and time to 1st SRE was significantly delayed (median time to SRE 13.6 mo v 8.4 mo, respectively; P = .00046; HR = .610; 95% CI, .461-.807). The proportion of pts with ECOG PS deterioration (≥ 2 points) was less in Ra-223 v pbo group at Wk 12 and Wk 24 (4%, 15/389 v 9%, 16/180 and 7%, 16/236 v 12%, 10/83, respectively). Time to ECOG PS deterioration (≥ 2 points) was significantly delayed by Ra-223 v pbo (P = .003; HR = .62; 95% CI, .46-.85). Conclusions: Ra-233 significantly delayed time to 1st SRE and SRE components, notably SCC. Fewer pts in the Ra-223 group had ECOG PS deterioration. Ra-223 improves OS with excellent safety and may provide a new standard of care for CRPC pts with bone mets. [Table: see text]

Impact of statins on outcomes in patients (pts) with metastatic castration resistant prostate cancer (mCRPC): Post-hoc analysis of data from COU-AA-301 and COU-AA-302 trials.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 230-230
Author(s):  
Guillermo de Velasco ◽  
David Lora ◽  
David Lorente ◽  
Toni K. Choueiri ◽  
Christopher Sweeney ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Randomized Clinical Trials ◽  
Cox Regression ◽  
Phase Iii ◽  
Interventional Treatment ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact ◽  
Statin Use

230 Background: Retrospective database studies have suggested that statins may have a positive impact on some mCRPC pts treated with prednisone (P)/abiraterone (AA) Methods: We conducted a post-hoc analysis of individual pt data of mCRPC pts treated with AA and/or P on randomized phase III clinical trials COU -AA-301 and COU-AA-302 to analyze the impact of statins on overall survival (OS). Statistical analyses were performed using the Kaplan Meier method and Cox regression adjusted for known prognostic factors. This study, was carried out under YODA Project #2016-1136 Results: 458 (41%) prechemotherapy pts and 348 (29%) postchemotherapy pts were statins users (Table). Improved OS was observed for mCPRC pts who were statins users in the postdocetaxel setting [HR: 0.82 (95% CI: 0.71 to 0.94); p = 0.006], and there was a trend towards a prolonged OS in the predocetaxel setting [HR: 0.89 (95% CI: 0.77 to 1.03); p = 0.13] adjusted by interventional treatment (AA and/or P). In the predocetaxel setting there were no significant differences in OS between the groups AA/P/non-statin users and placebo/P/statin users (p=0.3). In the multivariate analysis, patients randomized to AA/P who were statins users and presenting ECOG <2 had superior OS in the postdocetaxel setting. Similarly, age, ECOG and statin use were the strongest prognostic factors in the predocetaxel setting. Conclusions: In a post-hoc analysis of two prospective randomized clinical trials statin use was associated with superior OS in mCPRC pts treated with P or AA/P. Further studies are needed to confirm these results and guide use of statins as adjunct to P and A. [Table: see text]

Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study

2020 ◽  
Vol 20 (11) ◽  
pp. 887-895 ◽  
Author(s):  
Martina Catalano ◽  
Giandomenico Roviello ◽  
Raffaele Conca ◽  
Alberto D’Angelo ◽  
Valeria Emma Palmieri ◽  
...  
Keyword(s):  
Performance Status ◽  
Real Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Hematological Toxicity ◽  
Free Survival ◽  
Grade 3 ◽  
Ecog Ps ◽  
Prognostic And Predictive Markers

Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice. Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed. Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients. Conclusions: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

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